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Patendinõudlus eluteaduste valdkonnas

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Eluteaduste valdkonna intellektuaalse omandi kaitse . Patendiotsing, patendinõudlus.

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Patendinõudlus eluteaduste valdkonnas

  1. 1. Eluteaduste valdkonna intellektuaalse omandi kaitsePatendiotsing, patendinõudlusMargus Sarap, Euroopa patendivolinik17.aprill 2013, Tartu Biotehnoloogia Park
  2. 2. Biotehnoloogia erisused?4/2/2013 2Margus Sarap, 2013
  3. 3. Mittepatenditavad:bioloogilisi meetodeidbioloogilise aine, taime või loomasaamiseksvälja arvatud mikrobioloogilised meetodidmikroorganismide saamiseksleiutised, mida saab kasutada ainult ühekindla taimesordi või loomatõu puhulNB! Bioloogilise aine, taime või loomasaamise olemuselt bioloogiline meetodon meetod, mis täielikult põhineblooduslikul nähtusel, nagu ristamine jaselektsioon.Biotehnoloogia erisused?4/2/2013 3Margus Sarap, 2013
  4. 4. NB!Ühe ja sama patenditaotlusega saabtaotleda patendikaitset ainult üheleleiutisele või ühtse leiundusliku mõttegaseotud leiutiste kombinatsioonileBiotehnoloogia erisused?4/2/2013 4Margus Sarap, 2013
  5. 5. Biotehnoloogia erisused?1. A fluorescent probe for determining protein kinase activity with the general formula(I):(X-Y-Z)-L-F (I),whereinX-Y-Z is a bisubstrate-analog inhibitor of a protein kinase, in which X is acompound that binds to the ATP-binding pocket of the kinase and;Z is a compound that binds to the protein/peptide-binding domain of thekinase;Y is a an organic tether that connects X and Z and permits simultaneous bindingof X and Z to the active site of the kinase;F is a fluorescent dye which optical characteristics are changed in the course ofthe binding of (X-Y-Z)-L-F to the kinase;L is a linker (between the bisubstrate-analog inhibitor XYZ and fluorescent labelF) formed of a hydrocarbon chain, of other type of organic molecule or of part oforganic molecule; may be omitted in the probe and F directly bound to inhibitor XYZ.4/2/2013 5Margus Sarap, 2013
  6. 6. Biotehnoloogia erisused?1. A fluorescent probe for a protein kinase selected from the group consisting of:2. A kit comprising a fluorescent probe of claim 1.3. A bisubstrate-analog inhibitor of a basophilic protein kinase selected from the groupconsisting of:4. A method for determining the fraction of an active binding form of a protein kinase ina sample containing a fluorescent probe of claim 1 ...NONNOHOHNNH2ONON+-OOCONHONH-(D-Arg)6-(D-Lys)-C(=O)-NH2NHNS OOHNNHONH-(D-Arg)6-D-Lys(5-TAMRA)-C(O)NH2 NONNOHOHNNH2OONH-(D-Arg)6-(D-Lys)-C(=O)-NH2NNOO2NNHNHNONNOHOHNNH2ONON+-OOCONHONH-(D-Arg)6-(D-Lys)-C(=O)-NH2NHNS OOHNNHONH-(D-Arg)6-D-Lys(5-TAMRA)-C(O)NH2 NONNOHOHNNH2OONH-(D-Arg)6-(D-Lys)-C(=O)-NH2NNOO2NNHNH4/2/2013 6Margus Sarap, 2013patent US8,158,376
  7. 7. Patendidokumendi ülesehitus?•Leiutiskirjeldus – specification–Pealkiri - Title–Tehnika valdkond – Technical Field–Tehnika tase – Background Art–Leiutise olemus – Summary of invention–Jooniste loetelu – Brief description od drawings–Teostusnäi(de)ted – Description of embodiments–Viited – Recitation list–Patendinõudlus - Claims–Lühikokkuvõte - Abstract–Joonised - Drawings9.12.2011 7Sarap ja Partnerid, ©2011
  8. 8. Patendidokumendi erinevate osade tähenduKõige tähtsam – patendinõudlustehnilise lahenduse (leiutise) kaitseulatussõltumatu punktsõltuvad punktid9.12.2011 8Sarap ja Partnerid, ©2011
  9. 9. Patendidokumendi erinevate osade tähendus?Leiutiskirjeldusleiutise olemuse avaminetehnilise lahenduse täpne kirjeldus9.12.2011 9Sarap ja Partnerid, ©2011
  10. 10. VähiraviExplanation of terms•Heat shock protein 90 (HSP 90)Belongs to a class of proteins that protect cellswhen stressed by elevated temperatures;assists in tumour repression.•Heat shock protein 90 inhibitor (HSP 90inhibitor)Compounds which block the functioning of HSP90. Examples: geldanamycin or 17-alkylamino-17-desmethoxygeldanamycin (17-AAG).•Platinum coordination complexesPlatinum complexed with ligands. Thesecompounds are used as chemotherapeutics.Examples: cisplatin, carboplatin, oxaliplatin.17-AAG, R17 = alkylaminoOxaliplatinAllikas EPO materjalid , nõudluse tõlgendamine
  11. 11. LeiutisAn improved way of treating people suffering frombreast cancerby injecting a platinum coordination complex andoptionallyalso an HSP 90 inhibitor.The invention shows improved results by combiningthe two compounds. The specific combination ofoxaliplatin and 17-AAG has a synergistic effect.How can you protect it from imitation?• "An improved way" → Compared with what? (term notclear)• "Way of treating people" → Method of treatment of the human oranimal body by therapy = excludedfrom patentability• "A platinum coordination → Not a "method of treatment"; has acomplex " technical function → possible patentAllikas EPO materjalid , nõudluse tõlgendamine
  12. 12. Patent Claim: "A platinum coordination complex"How to patent this invention: claim it!Claiming a platinum coordination complex in general means trying to getvery broad protection. You already know that such complexes have beendescribed before.Patent Claim: "A platinum coordination complex for use in the treatment ofsuffering people."This wording also does not describe what you invented.Patent Claim: "A platinum coordination complex for use in the treatment ofbreast cancer."A prior art search will show whether the invention– as claimed – is actually new.Allikas EPO materjalid , nõudluse tõlgendamine
  13. 13. Tehnika taseme otsingu tulemusedThe prior art search found a journal article that discloses the invention.Cancer Treatment Reports 67(3) 235-238, 1983"... 2 [patients] with adrenocarcinomas in the breast ... were treatedwith cisplatin at a dose of 60 mg/m2 ..."A platinum coordination complex (i.e. cisplatin) for use in the treatmentof cancer is already known from this journal article!Allikas EPO materjalid , nõudluse tõlgendamine
  14. 14. Comparison of the two inventionsThe inventionas claimedCancer Treatment Reports"A platinum coordinationcomplex for use in thetreatment of breast cancer.""... 2 [patients] withadrenocarcinomas in thebreast ... were treatedwith cisplatin at a dose of 60mg/m2...""A combination of a platinumcoordination complex and anHSP 90 inhibitor for use ..."• New• Inventive step(the combined use showsimproved effects)Allikas EPO materjalid , nõudluse tõlgendamineNot new
  15. 15. Leiutist kaitsev nõudlusClaim to be filed:"A combination of a platinum coordination complex andan HSP 90 inhibitor for use in the treatment of breastcancer."Allikas EPO materjalid , nõudluse tõlgendamine
  16. 16. Sõltumatute nõudluste kasutamine kaitsetäiendamiseksThe patent should include both broad and specific claims.Broad:An independent claim (i.e. a claimstating the essential features ofthe invention) helps prevent thepatent from being circumvented.Specific:Dependent claims refer to anindependent claim andadditionally define preferredembodiments of the invention.Independent claimDependent claim 1Dependent claim 2Allikas EPO materjalid , nõudluse tõlgendamine
  17. 17. Patendiametile (EPO) esitatud taotlusCLAIM 1:"A combination of a platinum coordination complex and an HSP 90inhibitor for use in the treatment of breast cancer."Claim 2: "A combination according to claim 1, characterisedin that the HSP 90 inhibitor is 17-AAG."Claim 3: "A combination according to claim 1, characterisedin that the platinum coordination complex is oxaliplatin."The patent office will perform its own prior art search and thenconsider whether the invention AS CLAIMED is new and non-obvious.Claim 4: "A combination according to claim 2, characterisedin that the platinum coordination complex is oxaliplatin."Allikas EPO materjalid , nõudluse tõlgendamine
  18. 18. Tehnika tase EPO otsingust"Combination of HSP 90 inhibitor ... with anticancer agentslike carboplatin or cisplatin ... to inhibit ... growth of breastcancer cells.""Methods for enhancing the efficacy of cytotoxic agents throughthe use of HSP90 inhibitors"
  19. 19. EPO arvamusApplicants claim:"A combination of a platinumcoordination complex and an HSP 90inhibitor for use in the treatment ofbreast cancer."The invention according to claim 1is already shown and claimed inWO 02/15925.EPO response:Please amend your claims if you want your invention patented!A platinum coordination complex(e.g. cisplatin) and an HSP 90inhibitor were used inWO 02/15925 to treat breastcancer.
  20. 20. Edasine analüüs•Check the material revealed in the prior art searches:• Does the invention have any features NOT disclosed in theprior art?• What are the advantages of the invention compared withthe prior art?How can the claims be amended to reflect the inventionin a way that it is new (considering all the prior art)?•Did the EPO interpret any important features of theinvention differently to the inventor?Applicants reply: amendments to the application,explanation of the relationship between the inventionand the prior art
  21. 21. Synergism (more than additive)Claim 2: Features of Claim 1 +HSP90 inhibitor = 17-AAGClaim 4: Features of Claims 1 + 2 +Pt coordination complex = oxaliplatinCancer TreatmentReportsImproved effect (additive)Claim 3: Features of Claim 1 +Pt coordination complex = oxaliplatinClaim 1: Combination of HSP 90inhibitor and Pt coordination complexLeiutise võrdlus tehnika tasemegaTechnical features of the inventionWO 02/15925Advantages/technical resultNoNoNo NoNoNoNoNoNoNo
  22. 22. Analüüsi tulemusAlthough the individual elements of the invention are known, thecombination of specific compounds is not and it produces a new, uniquebenefit. But you have to take into account that:Claim 2 refers to the use of 17-AAG. To use this specific HSP 90 inhibitor isconsidered to be trivial, because WO 02/15925 recommends using anyHSP 90 inhibitor in combination with an anticancer agent.Claim 3 teaches the use of oxaliplatin. Again, since WO 02/15925 hints atthe use of any anticancer drug, the use of oxaliplatin is also considered tobe obvious.Claim 4 describes the use of the combination of oxaliplatin and 17-AAG.It is shown in the patent application that the combination produces asynergistic (= more than additive) effect. This is not disclosed inWO 02/15925.
  23. 23. Analüüsi tulemusedIf one compound is simply replaced by another without showing anyunexpected or surprising effect, such a replacement is frequentlyconsidered to represent routine for an expert.If an unexpected or surprising effect can be shown, then the invention isoften considered to be inventive (i.e. the invention is not obvious for anexpert working in the technical field).The use of 17-AAG and oxaliplatin, which leads to an unexpectedsynergistic combination, is therefore inventive.Invention(new + inventive)R17 = alkylamino
  24. 24. The present invention provides a method for treating cancer. Themethod involves the administration of an HSP90 inhibitor and aplatinum coordination complex, where the combined administrationprovides a synergistic effect.The HSP90 inhibitor for this aspect is typically 17-AAG, while theplatinum coordination complex is oxaliplatin.17-AAG combination in SKSBr-3 cells [0093] The following tableprovides CI values for combinations of 17-AAG and the platinumcomplexes oxaliplatin and cisplatin in an SKBr-3 cell assay ...EPOsse esitatud kirjeldus toetab parandusiDifferentto "CancerTreatment…"Differentto patentWO02/…Supportsinventivestep:differenttechnicalresult
  25. 25. Väljaantud patendi nõudlusClaim 1 as granted reads:"Medicament comprising 17-Alkylamino-17-desmethoxygeldanamycin(17-AAG) and oxaliplatin for use in the treatment of breast cancerin a patient."Response from EPO: granted!
  26. 26. EP1179050•1. A method for removal of protein kinase from a liquidcontaining the protein kinase by contacting the liquid with acarrier bound affinity ligand for the kinase, characterized in thatthe ligand is a bisubstrate inhibitor for the kinase whereas theligand is attached to the carrier.•2. The method of claim 1, characterized in that the bisubstrateinhibitor comprises the structure•C-(L) n-N•where•(a) C contains a structure inhibiting binding of thepeptide/protein substrate to the protein kinase,•(b) L is an organic linker,•(c) n is an integer 0 or 1, and•(d) N is an inhibitor competitively inhibiting binding of thenucleoside triphosphate (NTP) to the protein kinase;•and the structure is attached to the carrier via C.•3. The method of any one of claims 1-2, characterized in that C isa peptide substrate consensus sequence or a pseudosubstrateconsensus sequence.4/2/2013 Margus Sarap, 2013 26
  27. 27. Näide4/2/2013 Margus Sarap, 2013 27• 1. A method for removal of protein kinase from a liquid containing theprotein kinase by contacting the liquid with a carrier bound affinity ligandfor the kinase, characterized in that the affinity ligand is a bisubstrateinhibitor having a structure containing• - a moiety having the structure that is able to competitively inhibit bindingof the relevant nucleotide triphosphate (NTP) and• - a moiety having the structure that is able to competitively inhibit bindingof peptide or protein substrate• to the particular protein kinase molecule whereas the ligand is attached tothe carrier.• 2. The method of claim 1, characterized in that the bisubstrate inhibitorfor the particular protein kinase molecule comprises the structure• C-(L) n-N• where• (a) C contains a structure inhibiting binding of the peptide or proteinsubstrate to the protein kinase,• (b) L is an organic linker,• (c) n is an integer 0 or 1, and• (d) N is an inhibitor competitively inhibiting binding of the nucleosidetriphosphate (NTP) to the protein kinase.• 3. The method of any one of claims 1-2, characterized in that C is a peptidesubstrate consensus sequence or a pseudosubstrate consensus sequence.
  28. 28. • 1. A method for removal of protein kinase from a liquid containing the proteinkinase by contacting the liquid with an affinity ligand for the kinase bound to acarrier insoluble in aqueous media, characterized in that the affinity ligand is abisubstrate inhibitor having a structure containing simultaneously• - a moiety having the structure that is able to competitively inhibit binding of therelevant nucleotide triphosphate (NTP) and• - a non-phosphorylatable moiety having the structure that is able to competitivelyinhibit binding of peptide or protein substrate• whereas both moieties target the particular protein kinase molecule whereas theligand is attached to the carrier.• 2. The method of claim 1, characterized in that the bisubstrate inhibitor for theparticular protein kinase molecule comprises the structure• C-(L)n-N• where• (a) C contains a structure inhibiting binding of the peptide or protein substrate tothe protein kinase,• (b) L is an organic linker,• (c) n is an integer 0 or 1, and• (d) N is an inhibitor competitively inhibiting binding of the nucleoside triphosphate(NTP) to the protein kinase.• 3. The method of any one of claims 1-2, characterized in that C is a peptide substrateconsensus sequence or a pseudosubstrate consensus sequence.4/2/2013 Margus Sarap, 2013 28
  29. 29. 4/2/2013 Margus Sarap, 2013 29Claims1. A method for removal of protein kinase from a liquid containing the protein kinase bycontacting the liquid with an affinity ligand for the kinase bound to a carrier insoluble inaqueous media characterized in that the affinity ligand is a bisubstrate inhibitor having astructure containing simultaneously- a moiety having the structure that is able to competitively inhibit binding of the relevantnucleotide triphosphate (NTP) and- a non-phosphorylatable moiety having the structure that is able to competitively inhibitbinding of peptide orprotein substrate whereas both moieties target the particular protein kinase molecule whereasthe ligand is attached to the carrier.2. The method of claim 1, characterized in that the bisubstrate inhibitor for the particularprotein kinase molecule comprises the structureC-(L)n-Nwhere(a) C contains a structure inhibiting binding of the peptide or protein substrate to the proteinkinase,(b) L is an organic linker,(c) n is an integer 0 or 1, and(d) N is an inhibitor competitively inhibiting binding of the nucleoside triphosphate (NTP) tothe protein kinase.3. The method of any one of claim 2, characterized in that C is a peptide substrate consensussequence or a pseudosubstrate consensus sequence.
  30. 30. Nõudlused kellele•taotleja -> võimalikult lai kaitse•Patendiameti ekspert -> tehnika tase -> kitsendamine•konkurent• patendi vaidlustamine’• rikkumine•rikkuja4/2/2013 Margus Sarap, 2013 30
  31. 31. EE03157•1. Optiliselt puhas ühend, mida iseloomustab see,et ühend on (-)-5-metoksü-2-{[(4-metoksü-3,5-dimetüül-2-püridinüül)metüül]sulfinüül]-H-bensimidasooli Na+-, Mg2+-, Li+-, K+- Ca2+- või N+(R)4-sool, milles R on alküülrühm 1-4süsinikuaatomiga.4/2/2013 Margus Sarap, 2013 31Küsimused?-Mis on optilise puhtuse määr-tehnika tasemest tuntud Na, Mg soolad
  32. 32. Küsimused?Sarap ja PartneridPatendibürooMargus Sarappatent@patent.eetel 747 7058Kompanii 1c, TartuMikk Putkmikk.putk@patent.eetel 53 039 088Soo 46, Tallinn4/2/2013 32Margus Sarap, 2013www.patent.ee

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